Short-Term Efficacy and Safety of Desvenlafaxine in a Randomized, Placebo-Controlled Study of Perimenopausal and Postmenopausal Women With Major Depressive Disorder
J Clin Psychiatry 2010;71(8):1088-1096
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Background: The risk for major depressive disorder (MDD) increases during the menopausal transition. Nonetheless, no large, placebo-controlled studies have prospectively assessed the efficacy of antidepressants in perimenopausal or postmenopausal women. This randomized, double-blind, placebo-controlled trial evaluated the short-term efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) in perimenopausal and postmenopausal women with DSM-IV–defined MDD.
Method: 387 depressed perimenopausal and postmenopausal women aged 40 to 70 years were randomly assigned to placebo or desvenlafaxine (100 or 200 mg/d at the discretion of the investigator) in an 8-week, flexible-dose trial conducted from September 2006 to June 2008. The primary efficacy variable was change from baseline in 17-item Hamilton Depression Rating Scale (HDRS17) total score, analyzed using a mixed-effects model for repeated-measures analysis. Safety data were collected throughout the trial.
Results: The reduction in adjusted HDRS17 total scores from baseline to week 8 (mean daily dose after titration, 162 to 176 mg/d) was significantly greater for desvenlafaxine (–12.64) compared with placebo (–8.33; P < .001). Statistical separation from placebo was observed at week 1 and was sustained through week 8. Both the perimenopausal and postmenopausal subgroups achieved significant reductions in HDRS17 total scores with desvenlafaxine treatment (perimenopausal, P = .003; postmenopausal, P < .001). Response (58.6%) and remission (38.2%) rates were significantly higher for desvenlafaxine compared with placebo (31.6% [P < .001] and 22.4% [P = .008], respectively). In all, 19/256 (7.4%) desvenlafaxine-treated patients and 4/125 (3.2%) placebo-treated patients discontinued due to adverse events. Treatment-emergent adverse events were reported by 94/125 (75.2%) placebo-treated patients and 218/256 (85.2%) desvenlafaxine-treated patients.
Conclusions: Short-term treatment with desvenlafaxine was effective and generally well tolerated in perimenopausal and postmenopausal women with MDD.
Trial Registration: clinicaltrials.gov Identifier: NCT00369343
J Clin Psychiatry 2010;71(8):1088–1096
Submitted: February 1, 2010: accepted May 10, 2010 (doi:10.4088/JCP.10m06018blu).
Corresponding author: Susan G. Kornstein, MD, Mood Disorders Institute and Institute for Women’s Health, PO Box 980710, Department of Psychiatry, Richmond, VA 23209-0710 (firstname.lastname@example.org).